Monday, January 02, 2023 1:56:59 AM
On July 15, 2022 Update on the FULL FDA PMA Application. Quote---
ON July 13, 2022
Brian Thom. C.E.O.Reprted, "while the FDA does not respond in a piecemeal fashion in these discussions, their comments were very helpful and we conclude that the validation of certain elements of our Manufacturing process are necessary to assemble a complete portfolio of information that the FDA can then use to complete its review of our PMA application. We will work expeditiously with our partner in the coming weeks to accomplish these remaining tasks..
If i'm Not mistaking, we where Just informed actually 10 days ago. A third party Has varified the cemical anaysis to be Identical to the original used in surgeries. and it was procuded in the U.S.of A. by Ueec's Production Partners...Good Day..
In any Book I read, that puts us as Close to Aproval as we've Ever Been...
Ndakota
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